Clavicle Fractures Clinical Trial
Official title:
Comparison of Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial
Patients with acute, displaced fractures of the middle third of the clavicle will be randomly assigned into either the non-operative treatment group or the operative treatment group. The operative treatment group will be randomly assigned to repair with either an intramedullary device or a plate and screws.
Patients with acute, displaced fractures of the middle third of the clavicle will be randomly assigned into either the non-operative treatment group or the operative treatment group. The operative treatment group will be randomly assigned to repair with either an intramedullary device or a plate and screws. Pre-operative variables will be accounted for in detail. Operative variables including duration of surgery, length of incision, fluoroscopy times, blood loss, and quality of reduction will be recorded. Patients will be followed with regular post-operative visits in which radiographs and clinical examination will be performed. Outcome variables will include post-operative pain, time to union, union/non-union rate, return to work, return to activity, radiographic outcome, complication rates, incidence of repeat procedures, cosmesis, and functional outcome based on strength, range of motion, and scoring systems. There are five hypotheses for this study: 1) Operative treatment of acute displaced midshaft clavicle fractures will yield better patient-based functional outcomes when compared to nonoperative treatment as measured by physical assessment of strength and range of motion, standardized scoring systems and return to normal daily activities. 2) Operative treatment of acute displaced midshaft clavicle fractures will yield lower radiographically-determined nonunion rates, improved cosmesis and fewer complaints of residual pain when compared to nonoperative treatment. 3) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will be more efficacious than operative treatment with plate fixation as measured by duration of surgery, length of incision, fluoroscopy time, blood loss, and quality of reduction. 4) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will result in fewer complications than operative treatment with plate fixation including; nonunion rate, infection, incidence of repeat procedures, refracture rate, and hardware malfunction. 5) Operative treatment of acute displaced midshaft clavicle fractures with intramedullary pinning will yield lower radiographically-determined nonunion rates, improved cosmesis, and fewer complaints of residual pain when compared to operative treatment with plate fixation. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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